Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

February 15, 2022

Primary Completion Date

April 12, 2022

Study Completion Date

April 23, 2022

Conditions
Benign Paroxysmal Positional Vertigo
Interventions
DEVICE

Automated vertigo repositioning chair

"Patients are strapped to the chair with a safety harness, and video fenzel goggle are worn.~Automated diagnostic procedures are performed to determine vertigo subtype and orientation (Left/Right) (described below).~1. Dix-Hallpike (for posterior canal involvement)~2. Supine roll (for horizontal canal involvement)~3. (Optional) Deep Head Hanging (for anterior canal involvement)~If nystagmus is detected during automated diagnostic maneuvers, BPPV subtype is diagnosed, and corresponding automated treatment maneuver will be performed (described below).~1. Epley's and/or Semont's maneuver (for posterior canal involvement)~2. Barbecue and/or Gufoni's maneuver (for horizontal canal involvement)~3. Yacovino's maneuver (for anterior canal involvement)~10 minutes after performing automated treatment maneuver, provocative diagnostic test maneuver was performed once again to ensure successful intervention.~A follow-up was done one week later at the earliest."

OTHER

Canalith Reposition Maneuver

"Patients were seated on a examination table and given videonystagmography goggles (VNG).~Manual diagnostic procedures are performed to determine vertigo subtype and orientation.~The manual diagnostic procedures for Left and Right sided semicircular canals are:~1. Dix-Hallpike (for posterior canal involvement)~2. Supine roll and Bow and Lean (for horizontal canal involvement)~If nystagmus is detected during diagnostic maneuvers, BPPV subtype is diagnosed, and corresponding treatment maneuvers will be performed manually.~The automated treatment maneuvers are:~1. Epley's maneuver (for posterior canal involvement)~2. Barbecue and/or Gufoni's maneuver (for horizontal canal involvement)~Patients were called back for a follow up 2 days after performing manual treatment maneuvers. Provocative diagnostic testing maneuvers were performed again to ensure successful intervention.~A second follow-up was done one week later at the earliest."

Trial Locations (1)

34265

Haseki Sultangazi Training and Research Hospital, Istanbul

All Listed Sponsors
collaborator

Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences

UNKNOWN

lead

Stratejik Yenilikci Girisimler Ltd.

INDUSTRY